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NCT02465515 · ClinicalTrials.gov registry record · Phase 4

Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus

A Phase 4 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 4
Development phase
9,463
Enrollment target

NCT02465515: Completed Phase 4 study, sponsored by GlaxoSmithKline.

NCT02465515 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 9,463 participants, above the 517-participant average among 9,235 other Phase 4 trials with a reported enrollment target (1730% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02465515, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 4
Development phase
9,463 participants
Enrollment target

Study Summary

Albiglutide is an analogue of glucagon-like peptide-1 (GLP-1), used to treat type 2 diabetes This study will test whether albiglutide affects the occurrence of major cardiovascular events such as heart attacks or strokes and other important medical outcomes in persons with type 2 diabetes, when used alone or added to other diabetes treatments.

Primary Outcome

Time to MACE defined as the time to first occurrence of Cardiovascular Endpoint Committee (CEC)-adjudicated MACE (CV death, myocardial infarction \[MI\] or stroke) was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event

Interventions

  • BIOLOGICAL Albiglutide 30 mg
  • BIOLOGICAL Albiglutide 50 mg
  • BIOLOGICAL Albiglutide matching placebo

Trial Details

FieldValue
Enrollment Target 9,463 participants
Start Date 2015-07-01
Est. Completion 2018-03-14
Phase Phase 4
GlaxoSmithKline

1,345 total trials

What the finished NCT02465515 record still lists

NCT02465515 is an interventional study that assigns participants to a tested intervention. Its 9,463 participants enrollment target places it among the larger protocols in the corpus, above the 517-participant average among 9,235 other Phase 4 trials with a reported enrollment target (1730% higher).

The record links to 0 conditions, and to 3 interventions - of which Albiglutide 30 mg is the first listed.

NCT02465515 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02465515 about?

NCT02465515 is a clinical study titled "Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus". Albiglutide is an analogue of glucagon-like peptide-1 (GLP-1), used to treat type 2 diabetes This study will test whether albiglutide affects the occurrence of major cardiovascular events such as heart attacks or strokes and other important medical outcomes in persons with type 2 diabetes, when used...

What is the current status of trial NCT02465515?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 9,463 participants. The study started on 2015-07-01. Estimated completion is 2018-03-14.

What interventions are being tested in trial NCT02465515?

The interventions under investigation include: Albiglutide 30 mg (BIOLOGICAL), Albiglutide 50 mg (BIOLOGICAL), Albiglutide matching placebo (BIOLOGICAL).

Who is sponsoring clinical trial NCT02465515?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02465515's enrollment target sits among peer trials

9,463 9th of 2000 higher than 1,992 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02465515, the US trial registry maintained by the National Library of Medicine. NCT02465515 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.